Health product recall

2D/3D Mammography Systems

Brand(s)
Last updated

Summary

Product
2D/3D Mammography Systems
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Selenia Dimensions 2d/3d Mammography System-2d Main Unit 81003121439 81003121439
3dimensions Mammography System 3DM160700423 3DM160700423

Issue

Hologic has received a single report of a c-arm performing a significant unexpected movement during non-patient related use of the system. The investigation determined this event was due to a hardware component failure.

Recall start date: January 16, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Hologic, Inc.

36 Apple Ridge Road, Danbury, Connecticut, United States, 06810

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72660

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